alt text alt text

세포 및 유전자 치료

Your partner in developing cell, gene and other advanced therapies

Access multi-disciplinary, multi-modality experience to support your unique studies.

Get a patient-centric approach to optimize the development of your product.

Rely on our team to navigate complex logistics and implement practical solutions.

Experience matters when choosing a partner.

In the last 5 years

We’ve been honored to serve as a CRO partner of choice for our biotech and pharmaceutical customers as we’ve advanced their development. 

156

Advanced therapy studies

1,665

Sites

17,082명

환자

Our top therapeutic areas for cell and gene therapies include:

We’re here to seamlessly deliver your next cell or gene therapy trial.

Working as an extension of your team, we can offer you:

  • Experience with multiple modalities

    • CAR-T and AAV
    • Other viral and non-viral delivery systems (e.g., adenovirus, LNP)
    • Cell therapies (immune cell/stem cell, autologous/allogeneic, modified/non-modified)
    • Gene editing (e.g., CRISPR, meganucleases)
    • Advanced and complex therapeutics such as RNA-based therapies (e.g., ASOs, siRNAs), T-cell engagers and genetically modified organisms
  • Scientific and medical expertise

    Not only do we know how to work with these complex entities and recognize real or potential impacts on patient well-being, but we also understand the science behind how they work. We understand how these treatments are developed and manufactured, and how these complex characteristics impact the conduct of a clinical trial including:

    • Protocol development
    • Long-term follow-up (LTFU)
    • Development of companion diagnostics
    • Global regulatory requirements
    • Vendor qualification
    • Medical monitoring
  • Global operational solutions 

    The complexity of these therapies can involve numerous operational challenges defined by the asset in development and reflected in the trial footprint. We offer best practices, solutions and technologies and operational flexibility to optimize the conduct of your clinical trial, including, but not limited to:

    • Providing logistics support for autologous CAR-T cell therapies
    • Navigating site selection, activation, and overall study setup
    • Defining regulatory and GMO pathways timelines along with approvals
    • Reducing the patient burden for LTFU studies
    • Designing and implementing a program’s regulatory strategy, including early engagement (e.g., INTERACT, pre-IND), and when working with rare diseases and pediatrics
  • Customized training

    To ensure your team keeps up with complex and rapidly evolving technologies, we provide comprehensive custom training of all team members. Our Rare Diseases, Advanced Therapies and Pediatrics Team (RAPT) and Oncology members provide targeted, study-specific training, as well as a formal Cell and Gene Therapy Training curriculum.  

Serving as your agile partner for complex and novel clinical trials

Let our multidisciplinary experts put their insights and experience to work to advance your program. Together, we’ll improve your potential for success and make a difference in urgent unmet medical needs. 

Explore our related areas of expertise. 

 

Rare Diseases 소아과 종양학 Our Team (RAPT)

최신 소식 받기:
Fortrea 뉴스 및 공지사항을 구독하세요.